What is happening at Global Pharmacovigilance and Risk Management Strategies Conference

• Event Goals and Offerings

  • Important safety and pharmacovigilance regulatory updates from U.S, U.K, Europe, Japan, and China regions
  • Information on the new internationally harmonized guidance on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials
  • Technology and data heavy sessions discussing how new technology, artificial intelligence, machine learning, and visualization tools are advancing pharmacovigilance practices
  • Discussions on the impact of regulatory differences on global risk management organizations and the design and implementation of risk minimization materials
  • Panel discussion on key concerns smaller companies have encountered with the FDA Final Rule and FDA’s perspective regarding the concerns of smaller pharma companies
  • Interactive round table session to discuss safety updates and challenges with transgender population, underrepresented population, cell and gene therapy, and rare disease
  • Presentation by the DIA Clinical Safety and Pharmacovigilance Community chair

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• Why You Can’t Miss It

  • Network with like-minded professionals focused on safety and pharmacovigilance to discuss best practices and lessons learned
  • Participate in interactive sessions with speakers and other attendees discussing safety considerations for special populations
  • Evaluate the application of technology, visualization tools, machine learning, and artificial intelligence to advance safety practices
  • Gain insights from global regulatory speakers to stay current with the latest safety and pharmacovigilance updates in Europe, Asia, and United States

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  Short Course: Aggregate Safety Assessment Planning

  • Wednesday, January 25, 2023 10:00AM – 2:00PM ET

  This Short Course will be offered virtually – Join from anywhere! This session will describe the importance of proactive, multi-disciplinary planning for aggregate assessment of clinical trial safety data. A framework developed by the Aggregate Safety Assessment Planning (ASAP) task force of the DIA-ASA Interdisciplinary Safety Evaluation (DAISE) working group will be discussed; including identification of safety topics of interest and the use of preferred term groupings such as the recently issued FDA Medical Queries. In addition, approaches for the evaluation of safety data from ongoing clinical trials and how aggregate safety data assessment can support IND safety reporting decisions will be addressed. As part of this session, the identification of background event rates for the study population and potential challenges in their application will be discussed.

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  Short Course: Good Pharmacovigilance Practice (GVP) Operations Development - From Clinical Trial to Post Marketing

  • Wednesday, February 1, 2023 10:00AM – 2:00PM ET

  This Short Course will be offered virtually – Join from anywhere! This course is an introduction to Good Pharmacovigilance Practice (GVP) operations development, from clinical trials to the post-marketing environment. We will examine the laws within the US, EU, and other regions and discuss how to take those requirements and operationalize them into practice at a company. The audience will learn from a real-world example guiding them through the process of starting a safety unit at a small biotech, from staffing and vendor selection, to process implementation and preparing for the post-market experience.

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  Short Course: Pharmacovigilance and Risk Management Planning

  • February 5, 2023 – 9:00AM ET – 5:00PM ET

  This full-day in-person short course will focus on basic aspects of the regulatory framework for pharmacovigilance in the context of risk management planning and on the practical aspects of managing biopharmaceutical product risks in the context of benefits and the health care delivery system. The focus will be on the EU, UK, US, and Canada situations, but this will be supplemented with experience gained in other selected jurisdictions.

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Receive $150 off your forum registration by registering for any combination of at least two short courses and/or primers as well as the main forum. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Nearby Attractions & Things to Do:

• Pike & Rose is a friendly, walkable streets are home to a diverse and growing collection of restaurants, shopping and entertainment, free neighborhood Wi-Fi, as well as unique places to work and live.
• Tour Washington DC – click here to plan your tour.
• Smithsonian's National Zoo. The Smithsonian’s National Zoo is free and open every day of the year.
• National Air and Space Museum. The museum in Washington, DC is open and free timed-entry passes are required.
• Learn more about things to do by clicking here.

Exhibitor Case Study Events

February 6

• 10:20-10:50AM Exhibitor Sponsored Session/Non-CE: Case Study hosted by PharSafer | Case Processing – The Most Important Part of Pharmacovigilance? Or Rubbish in, rubbish out!
• 2:45-3:15PM Exhibitor Sponsored Session/Non-CE: Case Study hosted by Veeva Systems, Inc. | Beyond Compliance to Collaboration with Modern Content Management Safety Solutions

February 7

• 10:50-11:20AM Exhibitor Event/Non-CE: Case Study hosted by IQVIA | The Effectiveness of Automation Technology in Identifying Potential Adverse Events in Common Safety Data Sources